FDA 510(k)

autoSCORE

K-Number: K231068 · 2024-01-07

Decision Date2024-01-07

Product CodeOMB

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

autoSCORE is the device name listed in this FDA 510(k) record. The listed applicant is Holberg Eeg AS. It received FDA 510(k) clearance on 2024-01-07 under 510(k) number K231068. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the autoSCORE?

autoSCORE is a medical device that received FDA 510(k) clearance on 2024-01-07. The listed applicant is Holberg Eeg AS. The 510(k) number is K231068.

When did autoSCORE receive FDA 510(k) clearance?

autoSCORE received FDA 510(k) clearance on 2024-01-07, under 510(k) number K231068.

Who is the listed applicant for autoSCORE?

The FDA 510(k) record lists Holberg Eeg AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for autoSCORE?

The FDA product code for autoSCORE is OMB.

Other records listing Holberg Eeg AS as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243743autoSCORE (V 2.0.0)

Related Devices (Code: OMB)

K260998Ceribell Neurology Review SoftwareCeribell, Inc.K252070Ceribell Infant Seizure Detection SoftwareCeribell, Inc.K252160Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development, LLC K243743autoSCORE (V 2.0.0)Holberg Eeg AS K241589Ceribell Seizure Detection SoftwareCeribell, Inc.K242446Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development Corporation

Official Source

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